GalaFLEX ScaffoldRecalls & reported problems across all models

We found 6 models of GalaFLEX Scaffold by Tepha, Inc. in the FDA's device registry (GUDID). Together they are named in 167 adverse event reports in the FDA's MAUDE database, received between Mar 14, 2019 and Aug 26, 2026 — classified as 2 deaths, 155 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (148 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported GalaFLEX Scaffold problems

GalaFLEX Scaffold models

6 models, most reported first. Each model has its own page with its reports, recalls and device details.

• GalaFLEX Scaffold 100035-09

  Surgical Film
  2 deaths90 reports
• GalaFLEX Scaffold 100035-15

  Surgical Film
  64 reports
• GalaFLEX Scaffold 100035-14

  Surgical Film
  5 reports
• GalaFLEX Scaffold 100035-01

  Surgical Film
  4 reports
• GalaFLEX Scaffold 100035-05

  Surgical Film
  2 reports
• GalaFLEX Scaffold 100035-23

  Surgical Film
  2 reports

Recent GalaFLEX Scaffold adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryAug 26, 2026Patient-Device Incompatibility

  Attorney alleges that the patient underwent breast reconstruction surgery on or about (b)(6)2021, during which a GalaFlex Mesh was implanted following which patient had additional surgery on (b)(6)2022 to repair and explant GalaFlex Mesh. As alleged, the patient experienced additional surgical intervention, mental anguish, severe pain. Attorney alleges general allegations for "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient." It is also alleged that the device was defective.

  Patient problems: Pain

  MAUDE report 50449032 ↗
• InjuryJun 4, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT BILATERAL BREAST PTOSIS BREAST MASTOPEXY PROCEDURE ON (B)(6) 2024, DURING WHICH A GALAFLEX MESH WAS IMPLANTED. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED PAIN AT THE IMPLANTATION SITE, WHICH LED TO A SUBSEQUENT SURGICAL INTERVENTION. ON OR ABOUT (B)(6) 2024, PLAINTIFF REQUIRED A PROCEDURE TO REMOVE THE GALAFLEX MESH. ON OR ABOUT (B)(6) 2026, PLAINTIFF UNDERWENT AN ADDITIONAL SURGERY TO REMOVE THE GALAFLEX MESH. PLAINTIFF WAS INJURED SEVERELY AND PERMANENTLY. AS ALLEGED, THE PATIENT EXPERIENCED ADDITIONAL SURGICAL INTERVENTION, MENTAL ANGUISH AND CHRONIC PAIN. ATTORNEY ALLEGES GENERAL ALLEGATIONS FOR "PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED BY THE PATIENT." IT IS ALSO ALLEGED THAT THE DEVICE WAS DEFECTIVE.

  Patient problems: Pain

  MAUDE report 25390570 ↗
• InjuryApr 23, 2026Material Deformation

  AS REPORTED, ON (B)(6) 2025 DURING A BREAST AUGMENTATION PROCEDURE THE PATIENT WAS IMPLANTED WITH GALAFLEX IMPLANT. REPORTEDLY, ONE (1) MESH WAS DIVIDED INTO TWO (2) AND IMPLANTED BILATERALLY IN THE PATIENT. POST ONE (1) YEAR OF IMPLANTATION THE PATIENT HAD DISCOMFORT, PULLING SENSATIONS BILATERALLY FROM THE BOTTOM OF HER BREASTS, FEELING LIKE HER IMPLANTS ARE 'STUCK' IN HER MESH THAT HASN'T DISSOLVED IN A YEAR'S TIME, IRRITATING SENSATION MAKING PATIENT WANT TO "CRAWL OUT OF HER SKIN". IT WAS ALSO REPORTED THAT, THE AFFECTED SIDE IS BILATERALLY, MORE PRONOUNCED ON THE RIGHT. FOR THE POST-OPERATIVE COMPLICATIONS A REVISION SURGERY HAS BEEN SCHEDULED ON (B)(6) 2026. AS PER THE CLINICAL FINDINGS, THE PATIENT HAS GRADE ONE (1) PTOSIS AND THE MESH IS FOLDED IN THE RIGHT BREAST. PATIENT HAS BEEN ADVISED TO GET A MAMMOGRAM PRIOR TO HER UPCOMING SURGERY.

  Patient problems: Discomfort; Physical Asymmetry; Ptosis; Skin Inflammation/ Irritation

  MAUDE report 24967617 ↗
• InjuryJan 17, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, PATIENT WAS IMPLANTED WITH GALAFLEX MESH BY UNDERGOING BREAST AUGMENTATION MASTOPEXY ON (B)(6)2023. IT WAS REPORTED THAT PATIENT HAD A PERSISTENT ISSUE WITH PALPATION OF THE LATERAL ASPECT OF THE MESH ON THE RIGHT BREAST AND TENDERNESS IN THIS AREA. ON (B)(6)2024, PATIENT REPORTED PAIN DURING HOSPITAL VISIT FOR APPOINTMENT. HENCE, THE SURGEON RECOMMENDED A REVISION SURGICAL PROCEDURE TO REMOVE THE PALPABLE GALAFLEX AND REPLACE WITH GALAFLEX LITE. THE PROCEDURE IS SCHEDULED FOR (B)(6)2025.

  Patient problems: Pain

  MAUDE report 21178337 ↗
• InjuryDec 13, 2024Material Deformation; Material Deformation

  AS REPORTED, FOLLOWING BREAST IMPLANT SURGERY IN 2020, THE PATIENT UNDERWENT IMPLANT OF GALAFLEX AND REPLACEMENT OF BREAST IMPLANTS WITH SMALLER ONES IN (B)(6) 2022. IT WAS REPORTED THAT POST IMPLANT OF GALAFLEX, PATIENT HAD PAIN, DEVELOPED "IRON BREAST SYNDROME" AND ALSO A "LUMP" ON THE RIGHT LATERAL BREAST. IT WAS ALSO REPORTED THAT DURING LAST WEEK, THE PATIENT UNDERWENT REMOVAL OF THE "WADDED UP GALAFLEX".

  Patient problems: Breast Discomfort/Pain; Foreign Body In Patient

  MAUDE report 20925148 ↗
• InjuryNov 7, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, ON (B)(6) 2024 PATIENT UNDERWENT BILATERAL BREAST IMPLANT EXCHANGE NEOSUBPECTORAL POCKET PROCEDURE WITH IMPLANT OF GALAFLEX SCAFFOLD TO THE LOWER POLES. IT WAS REPORTED, THE MESH WAS CUT IN HALF, USED BILATERALLY AND 5 DAYS POST IMPLANT OF THE MESH PATIENT DIAGNOSED WITH INFECTION ONLY IN THE RIGHT BREAST. AS REPORTED ON (B)(6) 2024 THE MESH WAS REMOVED, AND PATIENT UNDERWENT SECOND SURGERY FOR EXPLORATION, WASHOUT AND DEBRIDEMENT ON (B)(6) 2024. PATIENT WAS ON ORAL AND IV ANTIBIOTICS BY INFECTIOUS DISEASE PHYSICIANS. ANTIBIOTICS STOPPED ON (B)(6) 2024 AND PICC LINE REMOVED (B)(6) 2024. IT WAS ALSO REPORTED THAT PATIENT IS SCHEDULED FOR A RIGHT BREAST AUGMENTATION, IMF INCISION, SUBPECTORAL POCKET AND RIGHT BREAST LOWER POLE SUPPORT WITH GALAFLEX ON (B)(6) 2024.

  Patient problems: Unspecified Infection

  MAUDE report 20630441 ↗
• MalfunctionJun 13, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, PATIENT UNDERWENT SURGICAL BREAST LIFT PROCEDURE WITH IMPLANT OF GALAFLEX ON (B)(6) 2021 AND REPORTED ¿IT¿S STILL FEELS HARD WHERE THE GALAFLEX WAS PLACED (3 YEARS LATER) AND NOT MUCH SUPPORT." IT WAS ALSO REPORTED THAT 240CC BREAST IMPLANTS EXCHANGE WAS ALSO PERFORMED.

  Patient problems: Ptosis

  MAUDE report 19527133 ↗
• InjuryJun 5, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, THE PATIENT UNDERWENT A BREAST AUGMENTATION WITH MASTOPEXY PROCEDURE WITH IMPLANT OF GALAFLEX ON (B)(6) 2021 AND REPORTED ¿GALAFLEX DID NOT WORK. THE PATIENT¿S TISSUE IS STILL WEAK AND MUST REDO HER PROCEDURE USING MORE GALAFLEX." IT WAS REPORTED THAT MESH WAS "BOTTOMING OUT (NO SUPPORT) APPROXIMATELY 1 YEAR AFTER SURGERY." IT WAS ALSO REPORTED THAT PATIENT IS "HEALTHY, ONLY TAKES VITAMINS."

  Patient problems: Physical Asymmetry

  MAUDE report 19467426 ↗
• InjuryMar 29, 2024Material Deformation; Material Deformation

  AS REPORTED, PATIENT UNDERWENT A MASTOPEXY PROCEDURE WITH IMPLANT EXCHANGE AND IMPLANT OF GALAFLEX MESH ON (B)(6) 2023. IT WAS REPORTED THAT PATIENT EXPERIENCED RIGHT BREAST BOTTOMING OUT THEREBY UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024 DURING WHICH SURGEON NOTICED THAT RIGHT BREAST LOWER POLE WAS SLIGHTLY TIGHT AND THE GALAFLEX MESH APPEARED TO HAVE SOME TYPE OF "DEFORMITY." IT WAS REPORTED THAT THE MESH WAS REMOVED AND NEW GALAFLEX MESH WAS IMPLANTED.

  Patient problems: Physical Asymmetry

  MAUDE report 19002938 ↗
• InjuryMar 23, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, PATIENT WHO HAD A HISTORY OF HEAVY SMOKING WAS DIAGNOSED WITH LARGE HEMATOMA ON RIGHT SIDE OF THE BREAST AND UNDERWENT RIGHT SIDE UNILATERAL BREAST REPAIR SURGERY (IMPLANT REMOVAL, CAPSULECTOMY, AND IMPLANT REPLACEMENT) WITH THE IMPLANT OF GALAFLEX ON (B)(6) 2022. IT WAS REPORTED THAT OVER 3 MONTHS LATER, PATIENT COULD FEEL THE GALAFLEX MESH AND IT DID NOT COMPLETELY INCORPORATE.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 16598986 ↗
• MalfunctionMar 10, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  AS REPORTED, UPON OPENING THE PRODUCT PACKAGE OF GALAFLEX, THERE WAS A SMALL PIN HOLE NOTED IN THE STERILE ENVELOPE. IT WAS REPORTED THAT THE MESH WAS NOT USED AND WAS DISCARDED. IT WAS ALSO REPORTED THAT ANOTHER MESH PIECE WAS USED AND THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16523420 ↗
• InjuryFeb 1, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT IN 1994 A FEMALE PATIENT WITH A MEDICAL HISTORY OF BREAST CANCER, MASTECTOMY UNDERWENT LEFT BREAST RECONSTRUCTION WITH A SILICONE IMPLANT AND AN AUGMENTATION IMPLANT ON RIGHT BREAST. OVER THE NEXT 24 YEARS SHE DEVELOPED PROGRESSIVE ASYMMETRY. ON (B)(6) 2018, THE PATIENT UNDERWENT REVISION SURGERY, DURING WHICH BOTH THE SILICONE IMPLANTS WERE REMOVED, AND IMPLANT OF GALAFLEX P4HB ON THE LEFT RECONSTRUCTION SIDE ONLY. THE PATIENT UNDERWENT MASTOPEXY ON RIGHT BREAST AND THREE FAT GRAFT SURGERIES OVER THE NEXT YEAR AND A HALF. AT THE END OF 2022, THE PATIENT WAS DIAGNOSED WITH THE MICRO CALCIFICATIONS AND 4 MM PRE-CANCER (DUCTAL CARCINOMA IN-SITU) IN RIGHT BREAST. ON (B)(6) 2022, THE PATIENT UNDERWENT RIGHT MASTECTOMY AND DIEP FLAP RECONSTRUCTION AND SILICONE TISSUE EXPANDERS WERE PLACED BILATERALLY. HER SURGERY WENT WELL. THE PATH REPORT SHOWED NO SIGN OF CANCER REMAINING AFTER THE NEEDLE BIOPSY. AS REPORTED, THE IMPLANTING SURGEON DID NOT CONSIDER THE PRE-CANCER DUCTAL CARCINOMA OCCURRENCE RIGHT BREAST TO BE AN OUTCOME OF THE USE OF GALAFLEX IN THE LEFT BREAST AND WAS REPORTED IN AN ABUNDANCE OF CAUTION TO DOCUMENT THE EVENT.

  Patient problems: Breast Cancer

  MAUDE report 16277294 ↗
• InjuryDec 22, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, THE PATIENT UNDERWENT BREAST RECONSTRUCTION PROCEDURE ON (B)(6) 2017 AND WAS IMPLANTED WITH GALAFLEX. IT WAS REPORTED THAT ABOUT 5-6 YEARS LATER, THE PATIENT WITH GALAFLEX (P4HB) IMPLANT MAY HAVE A BREAST CANCER RECURRENCE. IT WAS ALSO REPORTED THAT THE PATIENT IS CURRENTLY UNDERGOING DIAGNOSTIC TESTING TO CONFIRM POSSIBLE CANCER RECURRENCE.

  Patient problems: Breast Mass

  MAUDE report 16034987 ↗
• InjuryNov 9, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, ON (B)(6) 2018 SUBJECT 481-38 WAS TREATED WITH P4HB CONSTRUCT TO TREAT RIGHT BREAST CANCER MASTOPLEXY. DATE OF ONSET (B)(6) 2019 EXPERIENCED, MECHANICAL COLLAPSE OF THE P4HB CONSTRUCT, RIGHT BREAST. (B)(6) 2019 IDENTIFIES CONTINUATION OF TIGHTER SKIN ENVELOPE DUE TO RADIATION AND SCARRING PREVENTING SUFFICIENT PROJECTION FROM CHEST. ON (B)(6) 2019 REOPERATION PERFORMED WITH THE INITIAL CONSTRUCT THAT COLLAPSED BEING REMOVED AND REPLACED WITH A NEW CONSTRUCT USED.

  Patient problems: Pocket Erosion; Unspecified Reproductive System or Breast Problem

  MAUDE report 15763441 ↗
• InjuryNov 2, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  PER CLINICAL TRIAL (B)(4): PATIENT UNDERWENT PRIMARY BILATERAL PRE-PEC RECONSTRUCTION PROCEDURE. THE PROCEDURE WAS FOR ONCOLOGICAL REASON AND PATIENT WAS HOSPITALIZED FOR PROCEDURE ON (B)(6) 2020 (WITH DISCHARGE ON (B)(6) 2020). A FULL VERTICAL AND HORIZONTAL T INCISION WAS USED WITH A CONCOMITANT PROCEDURE OF ADIPODERMAL FLAP PLACEMENT. 2 PIECES OF GALAFLEX WERE USED. ON (B)(6) 2020, LEFT BREAST EXTRUSION WAS REPORTED. PATIENT TREATED WITH MEDICATION (LEVOFLOXACIN, DOXYCYCLINE, CIPRO, CLINDAMYCIN). ON (B)(6) 2020- ERYTHEMA/REDNESS OF LEFT BREAST WAS REPORTED. THERE WAS SIGNIFICANT PARTIAL AND FULL THICKNESS INJURIES INVOLVING THE NAC, WORSE ON THE LEFT THAN ON THE RIGHT. THERE WAS REDNESS AND SWELLING OF THE LEFT BREAST WITH DRAINAGE. THE PATIENT TREATED WITH EXCISIONAL DEBRIDEMENT AND COMPLEX WOUND CLOSURE RIGHT BREAST. ON (B)(6) 2020, THE PATIENT UNDERWENT LEFT BREAST REVISION RECONSTRUCTION; LEFT EXTRUDING BREAST IMPLANT AND MESH WAS REMOVED AND REPLACED WITH A NEW SMALLER BREAST IMPLANT AND NEW MESH. 1 NEW PIECE OF GALAFLEX (LEFT BREAST ONLY) WAS USED IN THIS PROCEDURE. ADDITIONALLY, COMPLEX WOUND CLOSURE, REDNESS/SWELLING ON THIS PATIENT FOR THE RIGHT BREAST. REVIEW OF MEDICA

  Patient problems: Erythema; Swelling/ Edema

  MAUDE report 15713680 ↗

Other Tepha, Inc. products

• GalaFORM 3D5 models · 76 reports
• GalaSHAPE 3D7 models · 74 reports
• GalaFLEX 3DR6 models · 27 reports